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Bridge Biotherapeutics’ idiopathic pulmonary fibrosis treatment wins orphan drug status
  • By Lee Han-soo
  • Published 2019.01.17 11:04
  • Updated 2019.01.17 11:04
  • comments 0

Bridge Biotherapeutics said Thursday that the U.S. Food and Drug Administration has granted an orphan drug designation (ODD) to BBT-877, an idiopathic pulmonary fibrosis treatment candidate.

FDA’s ODD is a system that helps smooth the development and approval of therapeutic drugs for rare or life-threatening diseases. ODD drugs receive tax holidays, exemption of license application fees, and seven-year monopoly after obtaining authorization.

LegoChem Biosciences first discovered BBT-877 and licensed exclusive global rights to Bridge Biotherapeutics for further development. BBT-877 inhibits autotaxin (ATX), which is known to play a role in various diseases, including fibrosis, autoimmune disease, and tumors.

The designation comes after the company applied for the orphan drug designation (ODD) to the FDA through KCRN, a contract research organization collaborating with the company, in October.

Bridge Biotherapeutics will begin phase 1 study of BBT-877 in the U.S. next month to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug candidate in healthy volunteers. The company expects to complete the trial by the end of this year.

"The company has reaffirmed the high unmet medical needs in idiopathic pulmonary fibrosis with the FDA’s ODD,” said Lee Gwang-hee, head of translational research at Bridge Biotherapeutics. “We will focus on accelerating development process of BBT-877 to achieve significant milestones in the near term.”

corea022@docdocdoc.co.kr

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